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EMA Draft Guideline on the Scientific Application and the practical Arrangements necessary to implement Regulation (EC) No 507/2006 on the Conditional Marketing Authorisation for Medicinal Products for Human Use falling within the Scope of Regulation (EC)

This draft guideline has been updated in order to reflect the experiences accumulated with conditional marketing authorisations and is therefore released for repeated public consultation.

According to Article 14(7) of Regulation (EC) No 726/2004, following consultation with the applicant, an authorisation may be granted subject to certain specific obligations, to be reviewed annually by the Agency. The list of these obligations shall be made publicly accessible. By way of derogation, such authorisation shall be valid for one year, on a renewable basis. This provision for a conditional marketing authorisation is further defined in Regulation (EC) No. 507/2006. Conditional marketing authorisation, in line with the defined scope and criteria and in the interest of public health, is usually appropriate for products where benefit-risk balance is such that the immediate availability outweighs the limitations of less comprehensive data than normally required, i.e. medicines with an established potential to address an unmet medical need.

This guideline addresses granting and renewing a conditional marketing authorization, as well as granting of a marketing authorisation not subject to specific obligations following their completion. This guideline should be followed unless otherwise justified